skills.rest
zhangzhang-111-i
zhangzhang-111-iCOMMUNITY
Explore all skills by this author →
GitHub

fda-consultant-specialist

Guide FDA regulatory pathways for 510(k), PMA, and De Novo submissions.

2|Updated Mar 13, 2026
Search Tags:#compliance#fda#regulatory#510k#medical device#hipaa#qsr
One-click install
npx skills add https://github.com/zhangzhang-111-i/claude-skills111 --skill fda-consultant-specialist-zhangzhang-111-i
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: fda-consultant-specialist
Source: https://github.com/zhangzhang-111-i/claude-skills111/tree/main/ra-qm-team/fda-consultant-specialist
Command: npx skills add https://github.com/zhangzhang-111-i/claude-skills111 --skill fda-consultant-specialist-zhangzhang-111-i

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill includes scripts (resource) and references (resource) components.

What problem does it solve?

This Skill provides expert guidance on FDA regulations for medical device companies, simplifying complex submission pathways and compliance requirements.

Core Features & Use Cases

  • Pathway Guidance: Understand 510(k), PMA, and De Novo submission processes.
  • Compliance Assistance: Ensure adherence to QSR (21 CFR 820), HIPAA, and device cybersecurity standards.
  • Use Case: A startup developing a new connected medical device needs to understand the cybersecurity and HIPAA requirements for their product. This Skill provides the necessary framework and guidance.

Quick Start

Use the fda-consultant-specialist skill to understand the 510(k) submission process.

Frequently Asked Questions about fda-consultant-specialist

High-intent search queries and answers about installing and using this skill.

FAQPage Schema
How do I determine the right FDA regulatory pathway for my medical device?▼

FDA regulatory pathways for medical devices depend on device classification, which this Skill evaluates to recommend the appropriate 510(k), PMA, or De Novo submission process based on your specific product characteristics and intended use.

What do I need to include in a 510(k) submission for FDA clearance?▼

A 510(k) submission requires demonstrating substantial equivalence to a predicate device, alongside compliance with Quality System Regulation (21 CFR 820) and applicable cybersecurity standards, which this Skill guides you through step by step.

When do I need to conduct a HIPAA assessment for my connected medical device?▼

HIPAA assessments for medical devices are required when your connected product handles protected health information, and this Skill provides the necessary framework to evaluate and ensure compliance with those specific data security requirements.

Does this FDA compliance guidance cover postmarket obligations for medical devices?▼

FDA compliance guidance here addresses postmarket obligations, ensuring your medical device continues to meet Quality System Regulation (QSR) per 21 CFR 820 and other regulatory requirements after the initial premarket notification approval.

What is the difference between PMA and De Novo submission processes for medical devices?▼

PMA (Premarket Approval) is for high-risk Class III devices requiring clinical data, while the De Novo pathway is for novel low-to-moderate risk devices without a valid predicate, distinctions this Skill clarifies for your regulatory planning.

Related Skills

Explore More Legal & Compliance Skills→
tractorjuicetractorjuice

arckit-uk-mdr-classification

Determine medical device classification and conformity assessment pathways under UK MDR 2002 and EU MDR 2017/745.

Community
Advanced
Tonybleything76Tonybleything76

fda-consultant-specialist

Guide FDA submission pathways and regulatory compliance for medical devices.

Community
Advanced
nimeshgurungnimeshgurung

fda-consultant-specialist

Provide FDA regulatory consulting for medical device compliance and submissions.

Community
Advanced
ovachieverovachiever
52

fda-consultant-specialist

Determine FDA submission pathways and plan regulatory strategy for medical devices.

Community
Advanced